Nwamaka Modebe
Clinical Research Associate at Pillar Clinical Research, LLC- Claim this Profile
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Bio
Experience
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Clinical Research Associate
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Pillar Clinical Research, LLC
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United States
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Research Services
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1 - 100 Employee
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Clinical Research Associate
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May 2022 - Present
Maintained Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participate in TMF and on-site audits as requested; Responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities. Assumed responsibility for site management and site staff performance including: monitoring all types of clinical trials and participated in all types of site visits. Ensured effective patient identification and recruitment plan as per protocol requirements. -Ensured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations. Show less
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Sun Research Institute
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Wellness and Fitness Services
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1 - 100 Employee
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Lead Clinical Coordinator
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Feb 2020 - Apr 2022
Acted as a liaison between CRO/Sponsors during site selection. Prepared site documents for site selection visits. Provided required documents to sponsor in preparation of new studies. Attended Investigator meetings. -Obtained informed consent. Performed Phlebotomy, EKGs, vitals, etc. Acted as a liaison between CRO/Sponsors during site selection. Prepared site documents for site selection visits. Provided required documents to sponsor in preparation of new studies. Attended Investigator meetings. -Obtained informed consent. Performed Phlebotomy, EKGs, vitals, etc.
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Pinnacle Clinical Research
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Clinical Research Coordinator
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May 2019 - Jan 2020
Informed subjects on the process of informed consent, institutional guidelines as well GCP. Maintained required records with CRF, EDC, IVRS, regulatory and temperature logs. Scheduled subjects in a timely manner to perform all screening procedures and Arranged shipment of sample boxes with a suitable air freight carrier and contacted collaborators or sponsor personnel to coordinate shipments and verified receipt of samples and keep records. Responsible for lab compliance including Environmental Health and Safety (EHS) and Radiation Safety Compliance (RSC). Dispensed investigational products, calculated dosages and provided patient education. Performed drug accountability Show less
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Education
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Chicago School of Phlebotomy
Phlebotomy -
University of Chicago
Global Clinical Research: The Process from Start to Finish -
University of Port Harcourt
Bachelor of Science - BS, Biochemistry